Regulatory Submissions, Information, and Document Management Forum
Highlights & Features
What is happening at Regulatory Submissions, Information, and Document Management Forum
- Four educational tracks: Regulatory Informatics Business, Regulatory Informatics Technology, Electronic Regulatory Submissions (ERS), and Electronic Document Management (EDM)
- One full day Preconference Primer *Additional fee required - coming soon!
- Half day Preconference Short Courses *Additional fee required - coming soon!
Track 1: Regulatory Informatics Business
addresses processes for obtaining and managing regulatory information through data management, governance, change control, organizational impact, and standards. Moreover, aimed at the key issues shaping the global regulatory and business environments.
Track 2: Regulatory Informatics Technology
focuses on technology and solutions for managing data, analytics, and emerging technologies to support efficient data control and quality.
Track 3: Electronic Regulatory Submissions (ERS)
track examines the processes, systems, and best practices for content management across the product lifecycle, including alignment with the RIM system for optimal use of regulatory information.
Track 4: Trial Master File (TMF) Inspection Readiness and Electronic Document Management (EDM)
track explores the submission planning and execution processes, considering regulatory requirements and new industry developments as well as internal reg ops best practices and alignment.